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5 Apr 2010, 6:00 am
Food and Drug Administration (FDA) recommend that GlaxoSmithKline's controversial diabetes drug Avandia be pulled from the market because it can cause heart attacks, the New York Times reports. [read post]
2 Jul 2024, 6:24 am
Food and Drug Administration (FDA) and The North Carolina Department of Agriculture (NCDA). [read post]
12 Jun 2024, 9:05 pm
Food and Drug Administration (FDA)—and when that use causes injury—consumers should have the option to sue the drug maker under state law, Simon contends. [read post]
8 Jun 2011, 5:12 pm
Jaensch – In what a federal grand jury charges was a several-months-long effort in 2010 to maintain their job security, a clinical trial investigator and clinical trial coordinator in Kansas allegedly falsified clinical drug trial study data in submissions to the Food and Drug Administration (“FDA”). [read post]
9 Apr 2020, 11:52 am
The pharma will ask the Food and Drug Administration and other regulators to add new information to the product label, which could result in a "black box" warning.... [read post]
18 Sep 2009, 2:40 am
As reported by the Associated Press, the Food and Drug Administration is requiring manufacturers of injected promethazine, a sedative also used to treat nausea and vomiting, to put the strongest warning possible on the product because it can cause tissue damage leading to amputation. [read post]
12 Dec 2011, 8:03 am
Food and Drug Administration and Federal Trade Commission issued seven warning letters to companies marketing over-the-counter HCG products that are labeled "homeopathic" for weight loss. [read post]
27 May 2011, 11:00 am
The Food and Drug Administration (FDA) issued a warning on March 4, 2011 that women who have used Topamax during pregnancy are more likely to have infants with birth defects, including cleft palate, cleft lip, and other facial malformations. [read post]
10 Jun 2016, 10:00 pm
Dan Flynn’s June 6 article in Food Safety News, “Third-party auditor certification: Not the only tool in the toolkit,” makes the case that the Food and Drug Administration should not overly rely on third-party audits to oversee the safety of imported foods under the Food Safety Modernization Act (FSMA). [read post]
24 May 2015, 10:03 pm
As with previous agendas for the Food and Drug Administration, finalizing the major rules of the Food Safety Modernization Act (FSMA) are a priority. [read post]
28 Feb 2010, 2:16 pm
The 334-page report by the Senate Finance Committee also criticized the Food and Drug Administration, saying that the federal agency that regulates food, tobacco and medications overlooked or overrode safety concerns found by its staff. [read post]
6 Oct 2009, 6:24 am
· Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices. [read post]
13 Sep 2017, 4:15 pm
Food and Drug Administration investigated a multistate outbreak of Salmonella Anatum infections. [read post]
29 Sep 2020, 3:40 pm
From the Abstract for this item we get these details about the current Beovu safety issue under investigation: Purpose: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of [Beovu (brolucizumab)] for treatment of neovascular age-related macular degeneration. [read post]
14 Sep 2017, 7:54 am
The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). [read post]
1 Apr 2018, 9:00 pm
A bakery in Washington, a donut manufacturer in Iowa, and a fruit and vegetable warehouse in New York are all on notice from the Food and Drug Administration for violations of U.S. food safety laws. [read post]
25 May 2011, 2:59 am
Food and Drug Administration in an appropriations markup on Tuesday. [read post]
10 Jan 2009, 7:44 pm
The Agriculture Department inspects about 20 percent of the food supply (meat and poultry), and the Food and Drug Administration is responsible for almost everything else. [read post]
29 Dec 2010, 1:59 am
Food and Drug Administration after federal agents seized all of its cheeses on Oct. 21.According to the FDA, the seizure was prompted by repeated testing by the Washington State Department of Agriculture and the FDA during the year that showed the persistent presence of Listeria monocytogenes, a dangerous foodborne pathogen, in the creamery's cheese products and facilities.Listeria can cause serious and sometimes fatal infections in young children, frail or elderly… [read post]
8 Aug 2024, 9:04 pm
At the end of last month, the Food and Drug Administration was again warning the public about a Kratom product, namely advising consumers not to consume OPMS Black Liquid Kratom, which is sold online and in some retail stores. [read post]
